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EBA submits over 500 amendments to drug bill
KYIV. Sept 24 (Interfax-Ukraine) – The European Business Association (EBA) has prepared more than 500 amendments to the bill On Medicines and asks the relevant Rada committee to continue the dialogue with industry representatives, according to a press release from the EBA on Thursday, September 23.
"It is necessary to make sure that no artificial barriers are created for the business, and sufficient transition periods are identified for the proposed changes. After all, these issues are interconnected with the availability of drugs for patients. Under any conditions, it is necessary to avoid negative impact on the market and limiting patients’ access to drugs," the message says.
At the same time, the business community asks the profile committee of the Rada to continue a professional dialogue with representatives of the industry, pointing out that the most effective way of resolving the issue is the general processing of all submitted proposals for the document and mutual approval of the final version of the edition for the second reading. According to the EBA, it is also necessary to involve lawyers, experts of international technical assistance projects and specialized state bodies in the work on the final revisions and the adoption of a new law for the pharmaceutical industry.
"Only by joint efforts will we be able to bring the pharmaceutical industry of Ukraine to the European level and provide Ukrainian patients with effective, high-quality, modern and safe medicines," the EBA says.
As reported, in July 2021, the Verkhovna Rada Committee on Public Health, Medical Assistance and Medical Insurance supported the bill No. 5547 "On Medicines".
The document provides for the introduction of European principles and procedures in the field of drug circulation, defined, in particular, by the fundamental EU Directive 2001/83. It is aimed at reducing administrative pressure on pharmaceutical market participants, increasing the level of transparency in the introduction of drugs on the Ukrainian market and their further turnover.
In addition, it provides for the protection of consumers from dangerous, ineffective and substandard drugs, as well as the formation of a favorable investment climate and overcoming technical barriers to international drug trade.
